Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis (Grapolyphen)

December 10, 2019 updated by: Thea Magrone, University of Bari

Oral Human Administration of Red Grape Polyphenol in Nickel-mediated Allergic Contact Dermatitis: an in Vitro Study

Nickel (Ni)-mediated allergic contact dermatitis (ACD) is a very common disease worldwide. Our previous findings demonstrated that in vitro supplementation of polyphenols, extracted from seeds of red grape (Nero di Troia cultivar), to peripheral lymphomonocytes from Ni-mediated ACD patients could reduce release of T helper (h)1 [interferon (IFN)-] and Th2 [interleukin (IL)-4] cytokines, on the one hand. On the other hand, IL-10 (an anti-inflammatory cytokine) levels increased with a reduction of IL-17 (an inflammatory cytokine). Also levels of nitric oxide (NO) decreased in response to polyphenol pretreatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nickel (Ni) is a transitional metal largely distributed in the environment whose continuous exposure is able to provoke local and systemic allergic contact dermatitis (ACD). Ni-mediated ACD is characterized by loss of epidermal integrity, urticaria/angioedema, flares, and itching, whose extent depends on many variables such as genetic, time of sensitization and environmental exposure.The aim of the present research is to verify whether the oral administration of polyphenols (NATUR-OX®) to patients with Ni-mediated ACD is able to modify immune parameters.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Thea Magrone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patient; Age: 25-60 Years; Ni-mediated ACD (positive reaction to the nickel patch test)

Exclusion Criteria:

  • Absence of other pathologies such as immune-mediated diseases, metabolic diseases (diabetes and obesity)
  • infectious episodes in the last month and intake of immunosuppressive drugs or drugs influencing the immune response.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: NATUR-OX Group (A)
Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm
Dietary supplement: NaturOx Group (A)
Comparison between dietary supplement and placebo
PLACEBO_COMPARATOR: Placebo Group (B)
Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)
Other: Placebo Group (B)
Comparison between dietary supplement and placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)
Time Frame: Baseline (T0)
At the time of enrollment (T0) concentrations of serum biomarkers (pg/ml) (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) will be evaluated in patients of which, one group (A) will assume polyphenols (NATUR-OX ) while the other group (B) will assume placebo. Of note, from each group 7 spontaneously dropouts occurred. An ELISA method will be use to analyze and to assess serum biomarker concentrations.
Baseline (T0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)
Time Frame: After 3 months (T1)
Serum biomarkers (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) (pg/ml) in the same patients of both groups A and B whose received for 3 months Polyphenols (NATUR-OX) and placebo, respectively, were evaluated. To analyze serum biomarkers an ELISA method were used .
After 3 months (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Investigators

  • Principal Investigator: Caterina CF Foti, MD, University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 16, 2018

Primary Completion (ACTUAL)

September 10, 2018

Study Completion (ACTUAL)

October 31, 2018

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (ACTUAL)

April 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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